BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURITY¿ CORE DR, MRI (US)

    MDR report key: 17086333 · Received June 8, 2023

    Report

    Report Number
    2017865-2023-22625
    Event Type
    Injury
    Date Received
    June 8, 2023
    Date of Event
    May 22, 2023
    Report Date
    August 22, 2023
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    DXY
    PMA / PMN Number
    P880086
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FIELD EVENT OF CAPTURING PROBLEM WAS NOT CONFIRMED. THE DEVICE WAS AT END OF LIFE (EOS) LEVEL UPON RECEIPT. ANALYSIS OF DEVICE IMAGE INDICATED DEVICE WAS PROGRAMMED TO HIGH FIELD SETTINGS DURING IMPLANT PERIOD. FURTHER ANALYSIS PERFORMED DID NOT FIND ANY ANOMALY WITH BATTERY VOLTAGE END OF SERVICE (EOS) LEVEL. LONGEVITY ASSESSMENT WAS PERFORMED, AND IMPLANT DURATION EXCEEDS TOTAL PROJECTED LONGEVITY INDICATING NORMAL BATTERY DEPLETION.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING IN CLINIC FOLLOW UP THAT THE PACEMAKER WAS EXHIBITING HIGH CAPTURE THRESHOLD. THE DEVICE WAS EXPLANTED AND SUCCESSFULLY REPLACED. THE PATIENT WAS STABLE AND ASYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268231 ENDURITY¿ CORE DR, MRI (US) IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC.(CRM-SYLMAR) PM2140 P000100864

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention